The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3351–3375 of 52938

  • HighFDA (Drugs)·D-0093-2026·2025-10-15

    Retatrutide injection recalled from one lot for lack of sterility assurance

    GenoGenix is recalling Retatrutide for Injection, 60mg/10mL vial, from a single lot for lack of assurance of sterility.

    Product
    Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2026·2025-10-15

    Chlorpromazine 25 mg fifty count packs recalled over nitrosamine impurity

    Major Pharmaceuticals is recalling 2,064 fifty-tablet blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because a nitrosamine impurity exceeded the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0041-2026·2025-10-15

    Preserved ascorbic acid injection recalled across all lots over sterility assurance

    GenoGenix is recalling preserved Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2026·2025-10-15

    Scleral reinforcement matrix recalled after complaints of early patch exposure

    CorNeat Vision is recalling 180 EverPatch+ units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

    Product
    EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0055-2026·2025-10-15

    L-Arginine for injection recalled across all lots over sterility assurance

    GenoGenix is recalling L-Arginine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2026·2025-10-15

    Chlorpromazine 200 mg tablets recalled over nitrosamine above recommended intake limit

    Major Pharmaceuticals is recalling 1,394 blister packs of Chlorpromazine Hydrochloride Tablets USP 200 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2026·2025-10-15

    BPC-157 with Thymosin Beta-4 recalled from three lots over sterility

    GenoGenix is recalling combined BPC-157/Thymosin Beta-4 for Injection across three lots for lack of assurance of sterility.

    Product
    BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0076-2026·2025-10-15

    Low solubility peptide solution recalled across all lots over sterility assurance

    GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2026·2025-10-15

    Sermorelin lyophilized powder recalled from one lot over sterility assurance

    GenoGenix is recalling Sermorelin lyophilized powder for reconstitution, 10mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.

    Product
    Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0065-2026·2025-10-15

    NAD+ injection recalled across all lots for lack of sterility assurance

    GenoGenix is recalling NAD+ injection at 50 mg/mL and 100 mg/mL in 10 mL multi-dose vials, covering all lots within expiry, for lack of assurance of sterility.

    Product
    NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0072-2026·2025-10-15

    CoQ10 for injection recalled across all lots over sterility assurance

    GenoGenix is recalling CoQ10 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2026·2025-10-15

    Angiography systems recalled over collimator returning to default region of interest

    Canon Medical Systems is recalling eight radiography/fluoroscopy systems because changing the acquisition program returns the collimator to a default ROI, leaving the X-ray area partially covered by a static image.

    Product
    This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0060-2026·2025-10-15

    Lipo MIC with B12 injection recalled across all lots over sterility

    GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0091-2026·2025-10-15

    Semaglutide injection recalled from two lots for lack of sterility assurance

    GenoGenix is recalling Semaglutide for Injection, 20 mg in 10 mL multi-dose vials, from two lots for lack of assurance of sterility.

    Product
    Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2026·2025-10-15

    Biotin for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Biotin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0013-2026·2025-10-15

    Wheat pellet pasta recalled for missing ingredient list and nutrition panel

    El Rojo Wholesale is recalling 2,904 units of El Rojo Pasta De Harina wheat pellets because the pack has no ingredient list, leaving wheat and Yellow No. 6 undeclared.

    Product
    El Rojo Pasta De Harina, Wheat Pellets. Net Wt 8 oz. (225g) UPC 0 35579-80871 6. Packaged and distributed by: El Rojo Wholesale, Maple Grove, MN 55469.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0038-2026·2025-10-15

    Miniaturized TEE probes recalled over reversed articulation from assembly error

    ImaCor is recalling 45 ClariTEE miniaturized TEE probes after a production assembly error left articulation reversed, so moving the lever forward anteflexed the tip instead of retroflexing it.

    Product
    ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2026·2025-10-15

    EDTA for injection recalled across all lots over sterility assurance

    GenoGenix is recalling EDTA for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2026·2025-10-15

    Shorter 8 French feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 840 NutraGlide 5 F - 8 F x 55 nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0087-2026·2025-10-15

    Thymosin Beta-4 injection recalled from one lot over sterility assurance

    GenoGenix is recalling Thymosin Beta-4 (TB4) for Injection, 15mg, in all presentations from a single lot for lack of assurance of sterility.

    Product
    Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2026·2025-10-15

    Larger nasal feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 200 NutraGlide 5 F - 8 F nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0058-2026·2025-10-15

    L-Glutamine for injection recalled across all lots over sterility assurance

    GenoGenix is recalling L-Glutamine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2026·2025-10-15

    Methylcobalamin B12 injection recalled across all lots over sterility assurance

    GenoGenix is recalling B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
    Category
    Drug
    Distribution
    Distributed nationwide